URGN - Earnings call transcript Q4 2019

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Operator

Good morning, ladies and gentlemen, thank you for standing by, and welcome to UroGen Pharma’s Fourth Quarter and Full-Year 2019 Financial Results and Business Update Conference Call.

It is now my pleasure to turn the call over to Kate Bechtold, Senior Director of Investor Relations for UroGen Pharma. Please go ahead.

Kate Bechtold

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma’s fourth quarter and full-year 2019 financial results and business update conference call.

XX, issued corporate release for highlights and ended we of an the morning, year recent our and December this a providing press overview quarter Earlier XXXX. financial results accessed The press website investors.urogen.com. the portion of at on release our Investors’ be can

me Pfreundschuh, are Barrett, Chief Chief call Financial President Chief Medical today Mark Officer; Officer. Dr. Schoenberg, the Officer; on and Joining Liz Executive and Peter

Senior Officer; Vice call for of will of be and the Jeff Chief Mullennix, us Bova, Joining this Operating President Commercial. Q&A Stephen portion

Liz a and of update. recent Mark questions. before an highlights our will then full-year open regulatory and financial overview we will for will and for up summary provide quarter call corporate the of our share developments clinical Peter fourth provide development the

these call, XX-Q statements SEC forward-looking morning, materially be of statements. will of indicated reminder, makes for As may of Pharma by from and to the Pharma’s making filings SEC section Risk make this time discussed on various XXXX. in today’s including the time. forward-looking differ constitute a Actual remarks from results the Various Harbor the Factors Securities future under call during prospects statements of Act forward-looking as a company’s Report and UroGen that UroGen Annual during the filed Reform important those with factors, Form result about those we Private other that provision this Litigation purposes Safe with plans certain expectations, the we

under page website of filings. These investors.urogen.com. XX-K UroGen’s company’s the Report available Form SEC the to at and company’s the read encourage are section of other the SEC Filings investors Annual all We Investors documents on

as we conference of our our provide date. representing information only upon views not should call all as represents be of as subsequent this relied addition, any In today, and views on

may statements to these make elect any forward-looking may we update no we obligation in statements information, to call of future on update we account future, point or undertake at new forward-looking on otherwise. some this While the events

over call the turn to now will Liz. I

Liz Barrett

tremendous Good today. I have time and opportunity UroGen Kate. you and CEO you, conference to pivotal for XXXX the over-delivered of progress on XXXX. achieve. morning, was thank and the commitments this that Thank everyone, out made a our the had on company, year we my to I’ve quarterly we’ve as call in last the for first joining and goals reflect set year us team

in of culmination year colleagues company’s XXXX for We us work have years transformative Pharma. the most believe the dedication of in many by and accomplishments the is This that our UroGen the up set history. of

urothelial first are are a better We option to low-grade in preparing option. bring who to upper for critical tract need cancer treatment the of non-surgical patients

or Food new of patients low-grade application, Our top priority was in NDA, the the and to submission of for complete with Administration for UTUC. to UGN-XXX drug the Drug U.S. rolling XXXX the treatment

months to At designation were to the from our the review the NDA. standard end priority of six shortens for the and submission accepted months priority the time that XX Their NDA. review of filing last for we FDA pleased review granted from announce the year,

Prescription approaching. Drug April Our Act, date goal or User of XX is Fee PDUFA, quickly

this treatment Fast FDA high the of Breakthrough Drug, for reminder, a Orphan for UGN-XXX UTUC, area. Track, in need and granted unmet Designations As previously the the reflecting low-grade

to FDA are their innovative and with We to this our therapy. pleased with the advance us willingness very partner discussions with

the expect publication rate excited date, of and importantly, by their year. final strong presented We and in the remain complete of a durability prestigious the data the we UGN-XXX and journal, XX-month six first-half to response

our UGN-XXX, potential we on await successful focused of as the As you can imagine, we’re approval. intensely launch

uro-oncology, unmet led a their and the and commercialization in the team, well high deep We’ve and Bova. field, oncology hired customers in team Jeff medical commercial all colleagues We’re in discussing by an place. and The meeting need outstanding and United well-prepared UTUC. for into low-grade with experience is States, training in

who We able be able reach force employed force a patient to We swiftly urology of XX% to practices. our very efficient the the population. account-based effectively representatives, of a believe nimble approach, will target reach will with sales be and XX

provide reps, In reimbursement installation educators managers, support a addition – field clinical seven and to seven the seven sales around managers small ensure we team access nurse and of have regional reimbursement business and reimbursement. to to training

seven three hired and more a identified who practice. in launch. we interested appropriately XXXX, planning into learning integration for have process, successful seamless Throughout in with earlier Patient commercial a of physicians UroGen our key engaged technology. MSLs, factors addition, the reimbursement In we about team and identification, physician

approximately UTUC is upon work with the we indication, X,XXX an will low-grade to in X,XXX and patients, identify nurse orphan closely navigators patients to diagnosis. with eligible practices the these First,

physicians Second, they confidence will drug, reimbursed because this they want that buy-and-bill is adopt. widely a will before get

assist will our to managers reimbursement, in reimbursement time. comprehensive done and on-site physicians is a that the have to be We correctly securing field in place ensure first program

hub an In with addition to to services secured have our field all team, reimbursement offices experienced assist and the we of access questions.

of need will it. be UGN-XXX to able access in patients So

has year-end. optimistic Notably, as notifications, notifications quarterly from moved of J-Code CMS we’re that we to have by will annual a J-Codes

a performed by Many we center can in secure More of be which also surgical where use C-Code these importantly, physicians procedures of will expect to October is hospital, necessary. or a a year. a this C-Code,

administration want seamless the And make is physician the preparation key We into – and element to UGN-XXX practices. for third practitioners. integration the convenient in

Pharmacy provide programs have support to a admixture to executed place clinic. recently urology We our in several this, to prepared National including with agreement partner

reconstituted prior needs to gel with be drug our installation. to Our

most do hospitals to use. with practices prefer ready this it can to While and have the some right themselves offices equipment,

installation. a will partner for hospital hub logistics Pharmacy customer the Our experience. or center to the a deliver be will support coordinated for surgery seamless ready All for

UGN-XXX. even only In XX% is year. in awareness a UroGen over of a physicians critical and and XXXX, Increasing about were was and UGN-XXX this component UroGen of initiative key of past adoption aware

patients. was research urologists option of it past we We As to desire it expect for launch. a of up their year, new be XX% and our AUA, to differentiated greater and treatment that even XX%, recent by patients from will know and of this The be market this and belief curve recurrent use treatment adoption continuum and diagnosed resectable as and that, newly our a typical disease. support research if patients, this the results those across unresectable well approved, as

into to be of treatment need the will surgery. FDA very recognized low-grade physician incorporate are options UTUC, their encouraged approval. there following Urologists delay opportunities And we radical multiple UGN-XXX to anticipated that

been patients, Our teams are excited have and waiting. who to bring UGN-XXX to fully preparing

UGN-XXX parts of the opportunities and are other the Beyond to patients anticipated we to U.S., launch bring in identify world. progressing research to

advance pipeline continue candidates. to also of We our leading uro-oncology

We bladder of are the candidate, accelerating intermediate low-grade development non-muscle invasive UGN-XXX, next treatment of risk cancer. with our for patients

approved UGN-XXX there better of to seeking drugs unmet are UGN-XXX, to no who cancer. options. Similar the low-grade the invasive standard the patients first-line address and with high for treatment Currently, need non-muscle of deserve we’re for improve care bladder

In resection transurethral has approximately the be in the our high for of risk particularly or failures. believe have repeatedly a disease. treatment the used classified alternative potential recurrence could provide XX,XXX current surgical options. bladder These is care, patients of patients need considered rate UGN-XXX intermediate it recurrence. We non-surgical and to as new targeting, population patients of of patients to treatment chronic of standard of we The address TURBT, of patient are tumor, low-grade specific

cohort from study response a data, share of patients months analysis were and Phase the II XX durability to Xb in first-half positive this We half complete from durability to interim year and of pleased the data including of of intend an year. the over OPTIMA last report patients

initiate the FDA give bring with of us will perspective to from on experts in the finalize path We Phase study the and this track this the regulatory compelling and a field study that quickest discussions and are our the remain We pivotal year. ongoing to important design patients. clinical medicine to in in X be to

believe revenue UGN-XXX than of sustainable business. which foundation build potential a providing $X could billion, We long-term the to growth strong peak be from greater UGN-XXX a that and

but cancer. is by of license is a X/X our provide the disease, UGN-XXX zalifrelimab we’ve we’re UGN-XXX advancing excited non-clinical initial encouraging bladder indication combination a Agenus. low-grade non-muscle previously Beyond agonist invasive work will we antibody UGN-XXX, anti-CTLA-X about further The Mark for and shared. supported details, from with high-grade TLR

We specialty cancers. and both adjacent local in for further medicines and and areas position other spaces, to novel urology delivery leadership explore building continue upon our

With more turn in to discuss the to that, detail. Mark? I’ll progress over our call Mark clinical and programs development

Mark Schoenberg

eventful Thank UroGen. you, year Liz. has been This past very for

that for Our cancer. as provides can be traditionally innovative surgery, an proprietary diseases and therapies bladder to applied treated such UTUC non-surgical low-grade developing by RTGel platform

the potential encouraged As complete of we remain first we await previously response medicine, presented. UGN-XXX, our by and durability data approval

XX% pivotal UTUC. rate complete the of with primary As OLYMPUS a reminder, patients the trial a endpoint Phase our X final demonstrated in low-grade of analysis response

evaluation. at Meier to estimated Durability six the estimated at months months and primary months, XX% response Kaplan XX% was XX disease median XX recurrence XX The of and was XX by time be care, patients to kidney who, patients the by tumors. according characterized standard to were having treated the candidates initially unresectable in be the immediate physician are treating study for would These the as current removal. endoscopically of after

given and dysuria, tract instruments treatment These being pain, mild events infection, common the to characterized stenosis, these of urologist, transient. ureteral and nausea, vomiting. most emergent moderate events to flank adverse are renal The were majority inseverity included hematuria, The disease treated and urinary adverse as utilized. impairment familiar the

urologist, publication anticipating the final TURBT. of intermediate intervention, to that the eagerly remains of low-grade the has As surgical Similar OLYMPUS low-grade bladder invasive UTUC, care Liz we results challenge of to cancer to primary from of in frequent endpoint or non-muscle using been recurrence future. stated, difficult near rate are the control trial a standard the given risk

The following and or an of entity population rates three centimeters clinical of rapid more recurrence. the defined tumors intermediate multifocality, by is two emerging characteristics, greater than risk

OPTIMA response patients, this In Xb September, intermediate study Phase low-grade complete from risk In response. of of NMIBC. interim of XX in or we complete XX with XX% patients, presented II patients the cohort data analysis a an achieved UGN-XXX

events no In infection. findings the urinary immersion this sharing reported. crematoria, there look events from adverse durability in most updated and forward complete response treatment We observed to months. of were adverse tract The were urination, frequency fatigue, next common analysis, interim few and serious the dysuria, study

both intermediate positive our UGN-XXX invasive clinical support bladder perspective, cancer. with about OLYMPUS in low-grade the These NMIBC. From study, from further to similar findings, low-grade results the UTUC molecular low-grade non-muscle excitement coupled patients very is and with risk advancing

a an impact and optimistic approximately treatment intermediate about to potential the UGN-XXX are immediate with the chronic We XX,XXX relapse. risk of have for patients non-surgical option provide of

with Liz actively the We year. the FDA look the we finalize Phase As design in study you on of to engaged expect to second-half X protocol forward our to of design mentioned, pivotal begin the and discussions the are the once in trial finalized. updating

on focused are disease, high-grade NMIBC for patients and programs a lead our remains low-grade physicians. While challenge clinical significant

Even disease, in Patients for approved population. significant fail limited and surgery had are radical new seen an require benefit with remains or associated morbidity is removal may medicines procedure the who as conservative cystectomy. high-grade bladder therapy we new recently these elderly This needed. with patients, options

data encouraging with for September, non-clinical combination UGN-XXX of zalifrelimab Based to in a alternative we BCG. patients care may treatment who as with provide fail on cystectomy shared believe agents UGN-XXX such therapeutic we a of standard

We year. development advance in human this in are continuing formulation studies initiating non-clinical of the later

provide will date. at program a details We on later the

would will Peter, to to who like call turn And I with over the financials. discuss that,

Peter Pfreundschuh

our launch and of everyone UGN-XXX later this and X well-capitalized is U.S. UroGen as development on trial UGN-XXX prepare for potential Mark, initiation advanced we you, morning good today’s to programs, year. including and of Phase approval call. clinical Thank

the and with cash. restricted million This $XXX.X closed marketable securities. in equivalents cash of excludes XXXX fourth We quarter cash,

reported fourth or $XX million, net full-year quarter million, and the XXXX, $X.XX share losses and $XXX.X $X.XX December share, we respectively. or ended For XX, per per of

period losses net for expense. of million, share compensation ended the XX, share stock-based fourth to losses quarter XXXX. $XX non-cash or $XX.X million, million, for XXXX respectively, $XX.X $X.XX same The $X.XX or in net December and full-year in compares This include and $X.X and per per approximately the million

to and $XX.X Research the fourth and XX, same were XXXX. respectively, December compared $XX.X XXXX $XX.X for periods full-year million million, the for million million and and $XX.X development quarter ended in expenses

Research full-year same for $X.X compared million in and include million stock-based development and respectively, December the compensation of as and $XX non-cash XX, $X expenses expenses XXXX, million for fourth to quarter XXXX. periods $X.X ended million and the

to our from Setting was attributable associated milestone with aside increased increase mainly of of Agenus API other we headcount to trial, Phase and year-on-year XXXX the non-cash with related to and commercial manufacturing activities, compensation related agreement stock-based clinical purchase increase for the activities activities. product supporting costs XXXX as clinical launch, payments costs the expense, prepare licensing trial for UGN-XXX Xb an increased and clinical Inc., UGN-XXX

million the XXXX in fourth the million administrative million were $XX.X expenses full-year compared XX, respectively, same million ended to December for $XX.X and $XX.X as and quarter and $XX.X for General period XXXX. and

expenses December XX, XXXX. General same and and million $XX.X million to and compensation ended for XXXX, and as in million of non-cash expense $XX.X administrative compared million full-year the periods $X.X fourth for $X.X include stock-based the quarter respectively,

from to expense. to the first consulting outside fees, of as costs increase of XXXX well mainly in anticipation other compensation and in company as headcount part The stock-based increase commercialization attributable and of XXXX as the was services, our buildout our of product, commercial related non-cash

company million and for largely launch on The XXXX having advancement attributable increase we current $XX in whole December organization XXXX plans, of operating our well-capitalized we our had XX, The $XXX XXXX, of As commercial a outstanding. in the shares pipeline. a anticipates ordinary expenses commercial Based are to for year. approximately continued $XXX strong a to of in million. place for operating is range expenses full million in

compensation for million XXXX million $XX to Non-cash million expected subject is anticipated to market other $X.X for of income a in expense conditions, conditions. market is range to and be XXXX non-operating $XX be to approximately subject to stock-based

turn I operator, call for that, like the questions. With to would over

Operator

you. Thank

question-and-answer question go now session. [Operator And our begin first from Derek will Stifel. the Archila comes Instructions] We Please ahead. from

Derek Archila

morning, for question. guys, taking good and the thanks Hey,

from few a Just us.

a you the September, sense the of of why end J-Code review? on J-Code end us could just would quarterly give that? when of they’re first a year, that timing this through by can said Just even by potentially So maybe just you have on doing the likely see kind the reimbursement, I you walk like us guess, the that a we

any those of are patients you additional of the UTUC the done overall in cost things. of in Thanks. that data? terms the And other terms healthcare economic then kind guys component, have of research And

Liz Barrett

question Derek, why the about give specifics turn Hi, then it’s answer can Jeff it and Liz. the the more cost over to on I’ll stay. you reason we

get have You’re they you give let details get it the could that. very dates. right, on we potentially I’ll but Jeff – specific earlier,

cost, the time, over to not kidney these management a but honest do be because of not have about of tried have issue of patients these managing actually after We data removal very the patients. to is long-term these been with lot successful, work around great really cost the there’s you, the patients with and

data. we to the a their talk and have – some impact things patients in a but some of So and removal We these do can with health data, sequela economic that know Mark not more about lot that of the they you associated health lives. economic kidney obviously,

reimbursement, And sort So if of question qualitatively briefly talk great. you Jeff, answer could you then just I’ll to that. specifically about the more on Mark more would let be that

Mark? So

Mark Schoenberg

other actually on removal recent this, that of story there’s are and who that, is of renal but downstream kidney increased of downstream know of the kidney reviewed also not who and sort peer have is chronic this undergo most elderly the which Derek. important effects the insufficiency, patients risk, the have The Hey, cardiac exacerbation of an short the removal obviously, effects of we one therefore disease. of only on comorbidities literature

important, not the and we’re most are that know population the exacerbation benign does elderly have we system, treatment comorbidities. a removal effects talking of about to the is other population with kidney to and costly in that do So that which disease, this respect downstream is probably the the procedure of that is

Liz Barrett

a associated that the aren’t costly with being cancer time, these over readily per talked kidney a I are the but patients fact the about managing the basis, remove on patient that it’s really we’ve the And Yes. and fact specifics of on unfortunately, most lot think that available. around

Jeff, can about specifically – or on talk Mark So, the J-Code? comment more just you reimbursement

Jeff Bova

pass-through correct, could CMS standpoint. CMS and it A thanks a that X. all early It we grant Yes, is so Sure, October a to C-Code. as Liz well. importance code depends unique for approval, possible us you’re that C-Code mentioned could Derek, an thanks, have the approval from a is timing a the on has quarterly J-Code as moved question. also permanent of October as

short, submit both the depends Once of in approved, ready codes. cards So, it on we’re approval. to timing – for

Derek Archila

the guys, Got congrats it. Great. on Thanks, progress. and

Liz Barrett

a Thanks Derek. lot, Thanks.

Operator

Our next question Please comes go from Chris from Howerton Jefferies. ahead.

Chris Howerton

Excellent. Thanks questions. the so much taking for

should coding Then forward So I year a pipeline. the expect the least, respect this respect to reimbursements – coding? first guess, the how on question Derek, how moving follow-up and to moving obviously to forward, launch. asked over, I from and those on evolve with Is – gross-to-nets there there we with the have at

Liz Barrett

it’s for in a not – a – discounting space. there’s this there’s Yes. lot not really of need

So doesn’t gross-to-net the codes don’t the – gross-to-net as impact really the much, really it that from right? perspective,

high type discount, not – have So, say, gross-to-net fairly we really at – it’s don’t to guiding be while we won’t but on right typical, see gross-to-net are the discounting that erosion. or these most competition really get that of is, we’re of see you need some your you need therapies where a a would the not specifically the see of XX% where what payers. with – high-end, on I That’s would

treatment. high typical you’ll see from we So, of and but your can types administration those what again, that’s see don’t gross-to-net. gross-to-net, a I non-surgical the percentages we’re say considering that sort you’ll about gross-to-net of very think only

and to So against be needing discount. others won’t this competing in space we

Chris Howerton

key features sticking for would team. points? or trial the guess, Is get whoever are are the alignment the that here, pivotal And to XXX the and you for Is – What key of endpoint? hope it kind then I with in on to size? respect regulators? it Okay. potential with an this suppose But Mark I what be design

that And that’d any of could we’re you getting has address buy-side as both be a been then, still to questions, those, versus involvement adjuvant that with you. corollary TURBT, an to point? in with on if discussion great? chemoablative terms So of respect because to there the least, the discussion, – therapy on Thank at

Mark Schoenberg

Chris. Thanks,

Let one take than me second the rather one, first. the first

So the therapy, just primary committed think, an that adjuvant and me let on reasons I this that, not everybody But we’re is them. for chemoablative therapy, a call reiterate understands. this to is

could, to it great physicians a to is value that, a but this have disease The approach who have only is in multifocal be is for need anesthesia, an addressed the and disease, chemoablative have who benefit And overall addressed, patients. which the primary the therefore, anesthesia care performed of elderly of that office. not without their disease to of important the patients a component it patients without can

to design, to respect of around The we appropriately we FDA. that issues powering differences the the design right, trial sure revolve size, types are the closely you’re to With show with are make groups between of power here working a questions you design to we’re think share and control and in deciding soon. hope aspire that characterization we group and around that with to finalizing some of alignment. we’re very good pretty that we I matter specific It’s just

Liz Barrett

hasn’t just we about these therapy, we the to they’ll that are patients And another adjuvant reason having TURBT. who Yes. avoid surgery worked. is on patients hope – because think why you chemoablative add the to get to that, to And – that actually – versus

perspective talked right really had side area, TURBT in surgery. why can’t has mitomycin effects just just from mitomycin So – you an reason of had times you’ve Mark give go about a after where the the of many in the and then, and

data patients we that, in shared, And benefit the those typically and CR the a have times out. is the all durability avoid patients, we high and in think not durability a the but that very I have actually best TURBT. several go So then patients potentially data, plays those on go to And in year they’ll would to have we’re these these waiting reasons, TURBT. data in

the but thanks So – for question.

Chris Howerton

but a can just with I respect maybe in you’re in high-grade. to XXX after, sneak Keytruda. maybe that recent more this Sure. particular one going for had not Obviously, similar we’ve And in if setting approval, the

for curious approval? how XXX and look the just will So for do you the enter positioning like when think you this clinic eventual

Mark Schoenberg

a extended recent think formulation an It’s we a keep of which approaching in great disease. refractory management now. one very to of Keytruda combination for which approval non-invasive administered question. would I mind about And in way the of things an That’s drug done as office, And of is period what’s of urologists systemically format is of a approach a this approval are XXX, or the time. the to intravesical currently permit treat an to is therapy that in the the familiar high-grade patients

believe I an personally disadvantage I I differentiated would advantage. Keytruda a represents a don’t that to think, the all, So it this And in it approval. completely be compared think represents approach, at fact,

Liz Barrett

Chris, I think that to rate right? I in thing really look, frankly. the other they’re we’re mean, happy, the seeing, keep is response mind,

getting patients on all patients are I being of these think small approved data, products that of a it’s the their have to for response. percentage they’re getting great you being actually at just good look But approved. a

think I a and being in – there’s unmet BCG. very high that post-BCG this hopefully, post-BCG able replace need then still to and eventually, So

it’s that So I in patient population. still high think unmet need a

by are in think area. that out number molecules see I this being you of studied that the there

Chris Howerton

of chose And to in ineligible taken patients yes, it. Well, delivery. not cystectomy the also, intravascular for then, of were terms take so course, point Right. those or

So, bit for skewed of a a sure. results

Liz Barrett

Oh, no, yes.

Chris Howerton

the so taking thanks Well, for questions. much

Liz Barrett

having the to CTLA-X I believe Yes, the sure. give a PD-X like with side that Mark that as being being treatments inhibitors, without to And, think, Absolutely. we the has effects – benefit side effects. a versus local is able some checkpoint give stated, able of inhibitor delivery associated the the what

Chris. So thanks a lot,

Operator

from Sachs. Choi Paul from Please go comes Goldman ahead. question next Our

Paul Choi

criterias and the or with any any ask selection observations refining morning, your just to to of I from probability or question wanted about here? regard thinking another thinking and you’re and questions. or you, Mark inclusion to with learnings everyone, I exclusion regard you’ve thanks taking earlier the that how success follow-up additional to about for boost maybe just data patient and wanted presented good team our to Thank interim

response how how question arm relative just thinking a as regard we think And about about – to with then the I had follow-up. rates established what’s literature? should And in the financial you’re a to the control then

Mark Schoenberg

you, Thank Paul.

really the So that I our right trial the design that the ongoing we think understand us at outset group happily, of picked Xb helped trial. has of

So AUA we that are we’ve on organization mentioned as of intermediate on focused professional a comporting characterized is group that based has definition disadvantages both other with the This risk of and the that all disease. population with Liz approach. earlier, criteria frequent intervention attendant of chronic recurrence, as surgical

So we’re we which right data, population our represent and you. definitions based based both studying currently believe the does that with current we’ve on also actually the on shared population,

So it I is what population is. think the

this just the how of these on group disease of that population of a We transurethral people group, would contemporary the patients control standard the recurrent about multiple And of which resection who know is course, after performance tumor. the resection. question care, occasions do to with bladder which answer be, have of is transurethral

could has as failures. So, and you many Liz as characterize people this surgical times, group of the is said

the rates kind sets are to be So have play but understood performance. regard XX% control hope we’re reviewed respect arm from the what XX% trial recurrence the level Obviously, expecting of peer based literature. in with we’ve that group on to expectations from to to our for what you anywhere that – I with to out, would

Liz Barrett

Yes.

said population did the looking patient is right. Paul, is it the at Just we’re start currently question. and running think we great XXX. which it population, Mark because launched where easy had study hospitals said, do And we I think, those when I us, financial reiterate, exactly a to it in to also patient able makes as are in the you same institutions, for And we to be XXX you

Paul Choi

Liz. you, Thank Yes.

Just just one as a follow-up, Peter. quick for a

to that if regard want XXXX? Just had bleed will launch upcoming inventory of any course the the a you regular to through see COGS you before to off with R&D transition over check double to

Peter Pfreundschuh

did you commercial related had UGN-XXX. fact associated other of we fact, that that of as as API, if inventory call, through pre-build our of costs of And guys well script R&D our Paul. in matter of question, build went go Good in the on actually expense advance we with a today’s the we you the with as launch to reference

So call good much, because expensed the that in in actual XXXX, in and It’ll development inventory and that expenses. up flip often expensed out will build fiscal be how question, it approval, was XXXX. those of our And to We any to upon believe further not embedded we research were costs appropriately. leading the also approval. specifically actually did through capitalizing P&L we’ll run but

will you at initial goods will actually So, that what skewed of see to not run be favorable for, of the inventory, is launch, will through which the cost least, the period pre-build of relative P&L.

Paul Choi

Great. Thanks for that.

Peter Pfreundschuh

No worries.

Operator

go question Our next Please ahead. C. comes from Ram H. Wainwright. Selvaraju from

Ram Selvaraju

question. Thanks of quick couple for A taking ones. the

the drug? workflow from point on nature and XPL the prescription of entry of describe comment the process point could maybe for of the administration organization of and prescription First, the the filling us you to

pharma you to of that extent performance maybe you’re history force to folks and performance promoting channel on with the us network? whether could the and was they’ve the whatever sales to able past? drugs you have their could the in And disclose perspective, background been you Board, if if kinds that? what of from those give with of Kind give to some as And us drugs, in that on specialty composition history to a a also this concept respect is then similar a sense sales prior distribution

Liz Barrett

we sales And ability and that some can and I answer of just want great representatives joining, to colleagues also I let that’s people just had think a headed. Yes, congratulate Jeff where to attract say testament to to in sure. that. Jeff, – we’re his I’ll But the no I shortage company. frankly, interested the on

context. specifically, questions to as channel, I as many companies, well the more be can but guidance know the additional it more him give Jeff, think around the came was distribution some from? the and would share different you where So, answer helpful force XPL that I around sales

Jeff Bova

thanks, The go come The – Ram. and itself through correct, orders the a actual through will Sure, order will XPL. in the hub. you’re

a go when other physician are our they like to that is this – in PROVENGE space, will administer a – script to there’ll an to patient, if drugs So be similar hub. the call XXX wants will number a radium-XXX. that process this then or hub that to That

The then surgery to product center. hospital or product specialty ship the the will XPL distributor and the then the distributor to will ship

Those B. different B particularly Part So, will as it where is Since Part distributor starts, through we we’re if pharmacy. a specialty a the distributor. yes, specialty drug, will than which XPLs well, are the drugs have specialty we go are that

Yes, With we regards get force. space. to are field able in talented to urology were from lot folks those of that the a the

Our variety has that average of experience. come the don’t cancer of a sort urology from have some anything space. years the any space company, hormone-sensitive particular. – amount in in genitourinary about or in come field They of from castrate-resistant from significant selling XX growth prostate experience – of in They a one drugs of an cancer force the companies prostate to

hopefully, helps. So that

Ram Selvaraju

additional ones. And Absolutely. then couple a of

to Or occur? definitely to is of wanted whether expecting in start sales clarify, XXXX? XXX to of that would booking you XQ kind still are open to as Just be able that

of whether might year? can perhaps or maybe position well sense to when question this for this OpEx as this some give next us then you be as might later a occur guidance? And revenue, perhaps, Peter, you a year, give And in

finally, whether UGN-XXX. that before know well? year, regard plan you don’t the see any sense readout I to if or the for the later? see you start end to also, this this this, to likely if give before trials end maybe combo should of if expect with additional if we And you. And wanted I development to should could us a year position of we any in of BotuGel but on a clinical information do comment, are Thank as clinical

Liz Barrett

answer two year. expect to this over studies the the then But last I in see too. I’ll that we’ll turn Yes. not would combination and Peter,

this but I escalation will through think, we we’ll studies be human dose dose and working optimization. in year, be

May is at the if you collaboration, BOTOX-Allergan clinicaltrials.gov, that completion the date do their On see look primary in you timeframe.

few data. a after they’ll that, months expect would so And that we have

materiality’s we’re their Now them on year, be what to and with of we up some at decide a the they we where be headed that able expect path to that. do end is will to by share, decision a least, have But as the will disclose perspective. forward information from obviously

And over couple to with I’ll turn answer questions. can that, and of he Peter it your first

Peter Pfreundschuh

of So into I’ll answer XXXX and we’ll I you first, revenue asked back kind the guidance know sales, about. question and which then

did our provide we regards So guidance income. expense, first here, to as or provide with income. and We saw operating with to non-operating earnings net revenue regards you line off, through compensation bottom share-based not guidance did release

If XX you speaking, typically look, usually eight guidance. revenue provide out companies the gate of biotech not of do out

call The that or you when they out that paradigm. don’t that, that do, various three following speaking, typically see two we’re do always think, right. do I it, for reasons, XX, of two get they, it

relative guidance income the think or cash we to approach and flow revenue bottom So provide provide not not line to is prudent to XXXX. guidance net obviously

into those numbers other, guys it’ll back one to the You provide or we if are so we speak. smart,

lot discussions we’ve Street, I on from analysts the of a our line. as colleagues, of many yourself, other around with had as the think well are gone your perspective, that the

those time, we’ve over had I of the think, course conversations.

where that think, line, there. had, numbers of right various now, out consensus are that with are the point I to they’re relatively in numbers kind we’ve the conversations we

to we’re guidance not per again, specific So, for se year. going this provide

revenue for the guidance to well I for booking this se. revenue as the that number to Street QX of we’ll guidance kind But you expect the book to year, earlier look again, guidance Should to With yourself, QX do can that. timing, that, have there have in of Street that revenue our QX that’s think, the we per as event. is provided as because year. consensus opportunity book to out is, the we a regards QX this it’s and will presumed QX,

Ram Selvaraju

Thank much. you very

Operator

Kaplan next comes from Thalmann. go from Please Our ahead. question Matt Ladenburg

Matthew Kaplan

or guess, morning, following initiative you as you describe guess, Jeff. more program, the XXX, of reimbursement some solutions program to, good Hi, provide us in questions. guys. Can of for approval? in the I it – Liz the really the I for uptake I question detail the launch drive guess, terms maybe patient more color around or Thanks taking ID a

Liz Barrett

why Yes, don’t the question? take sure. Jeff, you

Jeff Bova

the importance relationship of in Sure. Thanks, navigator earlier the with Liz nurse had Matt. practice. mentioned the the

folks be that those relationship, identify as So that you what out, done patients because for hired eligible experience, to it’ll pointed important have we’ve UGN-XXX. are is to that

certainly in place. that’s So

patients we that thing are other works those will mainly company identify with that The that have patients, EMR an that is, a that there’s obviously eligible. company help urology accounts it’s identify helps

sort there they’re so if recurrent in help of UTUC do patients that’ll work well. help and low-grade So with either a alert a them come have for as is patients, we’ll or those initially with rapid diagnosed, to

with approval. practice that being out we billing to reimbursement do timely down and very take help to that forms make regards The place reimbursement, the hospital the ensure accurate coding sure team in to with reimbursement upon reimbursement. and or team field With field correctly sit and a will have place to are reimbursement will filled managers the experienced

Matthew Kaplan

helpful. your guess, I gears Mark. for terms a you. Thank that’s shifting Okay, And question of in then just pipeline,

where think XXX, into risk For for paradigm fit I low-grade, will I the invasive intermediate bladder guess, guess, do treatment current you non-muscle it cancer?

Mark Schoenberg

Yes.

the actually that I that I elderly own problem way my surgery, and patients talking my population. psychological and a in a chronic know to to a exercise also for it’s practice, for become colleagues, think get appears for is with of a illness. sort these debilitating to tough patients physicians an So, rotate are physically and that, difficult managing perspective this I what both to through to and from they constantly this treat patients these know personally is futile and care chronic from

scientific that. this population. really These that know because you represents a the it perspective, I more of a disease, approach that the and think we results, in do is, expressed sophisticated, way is thinking It I different do can’t about surgically So treats entire contemporary the which cancers. are who it recurrent think, disease. from of field XXX multifocal have patients underscore And

good I to really be XXX need of population, applicable we but appreciate be that a it’s only alternative. to think physicians And that people think individuals, not I the we’re the is these better I these caring going job because do going readily better it’s So majority for a not doing and alternative. applicable to the to care think of

Matthew Kaplan

Great.

be because will used this these words, of it lieu of other in in aren’t as… lieu surgery, patients for this, really eligible So

Mark Schoenberg

really speculative Yes. once patients this it’s I part, mean, of how I more would mean, to imagine would imagine is that, alternative I – available, a on will because terms in very and I rational appear but appealing know physicians my to evolves. disease be this is it the we again, that

Liz Barrett

And, Matt, just – it’s Liz.

the incident majority patient this sort of So pool add some to that specify come right? talked around as patients, bladder prevalent of be the non-muscle can context you that. different invasive you about have recognize, population, Just think is the population, more your factors would in that that When a low-grade pool you the patient patient. patient of risk the intermediate Mark about, patients to low-grade here, the

And just those talk I will But population newly very because the continue lot – actually, about what a driver population heard very they total that patients. the to physicians think talk they’re about treat be patient diagnosed about patients have of frustrated, importantly, our a that us patients. of patient of Mark those these XX% patients that’s XX% are annual in, you’ve is come in and pool, a particularly don’t the and way new to big

when going with they they treat TURBT. first, a XXX to great And before work have get recognize XXX like to through in, seen several we TURBT going that feel likely as to alternative for patients a they’ll we come more them. to think doesn’t physicians begin already a with patient and if can response see want try then and to I So times who have – clearly those

the to for – I that bladder with so important many, many population cancer. understand non-muscle is that population just this low-grade years – patient patient So it’s a lives it’s invasive think

Matthew Kaplan

– mixture you. they then that the XXX in going question us you partner? role all more they that’s yes, to a last Are to is bit terms in how work? Okay, or National in little very clinics, for And going helpful. Pharmacy give the the terms be are of Thank how color of preparing going can to of use of,

Liz Barrett

their of clinics, actually the but nursing the be of do Yes. we want it. that equipment, the to majority expect choice, takes in they’ll – right want it some use where we ability physicians even they If to will the that we to the have most able I time time surgery mix either it they’ll hospitals, to may – will that. do have use and expect they to they mixing our majority into of mean, it the even wherever themselves, actually expect the be that and majority But physicians they in mix, the are that hospital they use partner. so have centers to want it, and

get a just was experience to the it team really and in their the basically at lot pharmacy sense they is Jeff that and and time happen what’s has this right that that’s past the will past you’re mix physician And of procedure extremely have So and his worked well. have doing going scheduled. it to his the experience,

me very doing. for that we’re exactly – we’re this make easy because to what will advantage, confident said, and – I our as this we physicians is have want is in So it work this

Matthew Kaplan

Great. a for makes of and questions Yes, Thanks sense. lot congrats taking on the…

Liz Barrett

Matt. Thanks, you. Thank

Operator

Maria comes Barbera ahead. next Our go Securities. question from National from Please

Maria Barbera

morning. Thank Good questions. taking you for my

wondering regulatory question for is been terms I UGN-XXX? Japan in And first in there any the the pathway The in progress conversations of regarding Europe, commercialization. ex-U.S. have with and was if regulators

Liz Barrett

honest regulatory the with knee-deep We be been with FDA. in the to here have team not that, has you, advanced

and resources – to start consultants until FDA Japan to in want So the to while take we consultation actually on actually need Europe, initial some and approval in U.S. we have – those in have we our wait we with before meetings. had the

the formal done. But a foundational to think be the lot we – what need matter meetings would And of just work. of a with official it’s we’ve But now actually I done and we having those authorities. regulatory understand

before, interaction stated have payer a regulatory past, really that Europe, of a some We interaction. in not in it’s before. did more It’s As the regulator.

need Germany, financially XXX. it the a and see to into into see to we are decent on getting to which for and with viable be UK, working us countries And the get to what would authorities able they the really that And big ensure understand German go and we’re can so be the to make Europe. France reimbursement would – even

able well. we but U.S., XXX, As countries world and around want be it at give as to to even in in approach we the some only us that hopefully a would approval a study not the look regulatory design other

that be expect a So we to global study.

that I So hope helps.

Maria Barbera

I enrolled retreatment great. extension if could study? XXX, wondering was the any you Okay, And patients staying been in share have then if with

Liz Barrett

And launch no. we have guess, there the an to at a begin study. of news – because we as haven’t for look another we’ll retreatment I been there lot alternative actually, been to Unfortunately, haven’t lot, recurrence. a is,

bad that’s sort news news of a of but anything. than more so good news, good a story, that’s And

And do would wouldn’t We we there important it’s retreat, all retreat. that also that they to we wouldn’t they’ve that physicians reason do be off-label an that they seen in believe in use retreat that, would conversations that durability not with and the data, medicines. that our study, believe they viable our they for any would have that assuming these be of type gather think of But we’ve patients. said the us

a post-approval. data gather to like, So we to and X have maybe But do Phase on looks get want we’ll to do it retreatment. continue study

Maria Barbera

early to the them, from believe said went the And field been later? I what XXXX. the I of conversations get those when think, any out to And with region. now the are how there then medical early field have out have science way in license, the I Okay. in since is the they you I’m you seven wondering year XXXX they per was the regarding physicians? one assuming And if about MSLs XXXX since feedback changed early interactions And

Liz Barrett

the promotional important peer-to-peer of to physicians. it’s to mind conversations and really It’s able role with have an MSL, educational be of keep think is a to in Well, The right? an role not role role. an MSL I really

with don’t appropriate track type of an sort events we to not So, track. promotional It’s MSL.

we’ve I’ll not and talk to So tell though, UroGen over about him made over to the of specifically, our and you as last physicians, it can perception company I but let MSL and year. their the awareness turn what products what their and you a progress Jeff and

received? the So most about research recent to Jeff, talk we just want that do you

Jeff Bova

Sure.

around So the the have and with the a really conference MSLs XXX. to We of regards for have UGN-XXX a last urology couple to data that relevant year, are been, clinical in help every to huge is discussion of factors. – sort that’s for a attended we’ve they been able published

So increase from there’s strong that an having a significant in just we meetings. interest saw presence XXXX, a at these

awareness. in that Liz to research is is alluding around The

So a to shot awareness XX%. XX% the company of discussions, ago, for over the had around is – those itself. and for our year around XX%, was XX% presence we’ve UGN-XXX up awareness and Because that that

are quarters three physicians So of XXX. aware those of

the are Congresses, have approval. then we and the when that we or a at question approved is, when often think the specific can off You mind having questions, for product. booth of in number a waiting And a significant approved? patients there’s interest around amount imagine are we they’re we their get physicians of I

that something the raising can and have is MSLs capture done job we can great measure, we awareness there that So and a that. out

Maria Barbera

in the with doing there Okay. And any formulation is update were Janssen? study on then feasibility lastly, of terms pipeline, that you

Liz Barrett

Not at this time, no.

Maria Barbera

questions. the taking Okay. for Thank you

Liz Barrett

you. Thank

Operator

time. remarks. President closing now this no I Barrett, CEO, to turn showing and I’m further back the over for call UroGen’s questions Liz at will

Liz Barrett

operator. in to We care advancing to on mission. that Thank new and a must diseases, together cancers urologic put mission specialty patient And incredibly that accomplished of and in treatments pioneer say, XXXX. we’ve and improve proud all our I’m I we’re really you, team

be today events what approval given of We’re many beginning excited to the that the I’m especially about able UroGen horizon, the confident And achieve. will the key demonstrated just that on is UGN-XXX. what of potential we’ve this

morning your appreciate support. we of really this interest time and and So continued your all

Thank you. can So, you disconnect. now operator,

Operator

conference. you today’s you participating, Thank may disconnect. you, Thank now gentlemen. for This ladies and and concludes

UroGen Pharma (URGN) 2 Mar 202019 Q4 Earnings call transcript